Use caution Medical device recall · FDA · Published November 11, 2021

Medtronic Stealthstation Cranial Software Recall: Incorrect Needle Position Risk

Medtronic recalls Stealthstation Cranial Software versions 3.1.1-3.1.2 and 3.1.3 due to potential incorrect biopsy needle positioning during cranial procedures, risking tissue injury and additional surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0383-2022Medical device Medtronic ›

Use caution until it’s fixed

Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy needle, which may result in prolonged procedure, the need for additional surgical procedure, tissue injury.

Take action

Contact the company

Recalling firmMedtronic Navigation, Inc.826 Coal Creek Cir · Louisville, CO 80027-9710

✎ GovInfoNow plain-language explainer

Medtronic is recalling specific versions of its Stealthstation Cranial software because it can display incorrect biopsy needle positions during cranial procedures. This risk could lead to longer surgeries, additional procedures, or tissue damage. Affected users should contact Medtronic for details on the fix. Read more at govinfonow.com/recall/61549-medtronic-stealthstation-cranial-software-recall-incorrect-needle-position-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61549-medtronic-stealthstation-cranial-software-recall-incorrect-needle-position-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0383-2022

Cite this page

“Medtronic Stealthstation Cranial Software Recall: Incorrect Needle Position Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61549-medtronic-stealthstation-cranial-software-recall-incorrect-needle-position-risk. Based on FDA recall #Z-0383-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0383-2022%22&limit=1).

The FDA announced on 2021-11-11 that Medtronic Navigation, Inc. is recalling Stealthstation Systems with specific cranial software versions due to a hazard of incorrect needle position display. This error may result in prolonged procedures, additional surgeries, or tissue injury.

How to tell if you have it

Stealthstation System w/ Stealthstation Cranial Software 3.1.1, 3.1.2, 3.1. or SynergyCranial Software
Synergy Cranial, Model: 9733763
StealthStation Cranial, Model: 9735585; 9733763, Version: 2.2.8
9735585, Versions: 3.1.1, 3.1.2, 3.1.3

The hazard

According to the FDA, the cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen. This may display an incorrect position of the biopsy needle, which may result in prolonged procedure, the need for additional surgical procedure, or tissue injury.

Context

GovInfoNow's records show Medtronic Navigation, Inc. has 25 other recalls on record since 2017-06-07. Recent brand recalls include issues with PIN surgical pins not fitting patient reference frames (2024-12-04), flipped images in StealthStation S8 App versions (2024-08-22), and missing digits during neurosurgery (2024-03-26). Other recent recalls of similar products include Howmedica Stryker CranialMask Tracker software errors (2025-11-12), Medtronic Vanta CP App software risks (2025-12-03), and Hitachi Proton Beam Therapy System positioning anomalies (2026-02-06).

How to tell if you have this one

Check if your software version is 3.1.1, 3.1.2, or 3.1.3 for Stealthstation Cranial or Synergy Cranial. Model numbers 9733763 (StealthStation Cranial) or 9735585 (Synergy Cranial) with the specified versions are affected.

Brand
Medtronic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Medtronic
Reach out to Medtronic directly to confirm your software version and get instructions for the fix.

Where it went and when

Where it was distributed

Distributed in 48 states and D.C. and Puerto Rico.

FDA distribution: “US: MN, FL, MD, IL, AK, NE, NH, PA, ND, AR, CA, WI, NJ, GA, SD, AZ, KY, AL, MS, MO, TX, MI, MT, OH, NY, VA, MA, CT, TN, WV, WA, NC, CO, NV, ME, LA, DE, NM, IN, UT, DC, OR, SC, OK, IA, HI, ID, KS, WY, MN, PR OUS: AU, BN, GU, JP, KR, MY, NZ,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 48 days after the firm started it.

Nov 11, 2021Firm started the recall
Dec 22, 2021FDA classified it Class I
Dec 29, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the software immediately?

No, but you should contact Medtronic to get the fix as soon as possible to avoid risks.

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Link to this recall

<a href="https://govinfonow.com/recall/61549-medtronic-stealthstation-cranial-software-recall-incorrect-needle-position-risk">Medtronic Stealthstation Cranial Software Recall: Incorrect Needle Position Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0383-2022 (November 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0383-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.